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OSP finalist
Action period
  1. Letter

    Action date:
    FDA Application:
    NDA207865
    Drug:
    Emend
    Active Ingredients:
    Aprepitant
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207865 NDA APPROVAL Merck Sharp & Dohme Corp...
    • ...NDA 207865 Page 2 patient package insert). Information on submitting SPL files using eLIST may be found in the guidance for industry SPL Standard...
  2. Label

    Action date:
    FDA Application:
    NDA207844
    Drug:
    Albenza
    Active Ingredients:
    Albendazole
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ALBENZA® safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1.1 Neurocysticercosis ALBENZA is indicated for the treatment of parenchymal...
  3. Letter

    Action date:
    FDA Application:
    NDA207844
    Drug:
    Albenza
    Active Ingredients:
    Albendazole
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207844 NDA APPROVAL Amedra Pharmaceuticals LLC...
    • ...NDA 207844 Page 2 CONTENT OF LABELING As soon as possible, but no later than 14 days from the date of this letter, submit the content of labeling [21...
  4. Summary Review

    Action date:
    FDA Application:
    NDA207844
    Drug:
    Albenza
    Active Ingredients:
    Albendazole
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 207 4880rig15000 SUMMARY REVIEW...
    • ...NDA 207844. Albendazole chewable tablets Division Director Decisional Memo Date (electronic stamp) From...
  5. Label

    Action date:
    FDA Application:
    NDA207793
    Drug:
    Onivyde
    Active Ingredients:
    Irinotecan hydrochloride
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all of the information needed to use ONIVYDE™ safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION WARNING: SEVERE NEUTROPENIA and SEVERE DIARRHEA Fatal neutropenic sepsis occurred in 0.8% of patients receiving ONIVYDE...
  6. Letter

    Action date:
    FDA Application:
    NDA207793
    Drug:
    Onivyde
    Active Ingredients:
    Irinotecan hydrochloride
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207793 NDA APPROVAL Merrimack Pharmaceuticals, Inc...
    • ...NDA 207793 Page 2 CONTENT OF LABELING As soon as possible, but no later than 14 days from the date of this letter, submit the content of labeling...
  7. Label

    Action date:
    FDA Application:
    NDA207768
    Drug:
    Tuzistra xr
    Active Ingredients:
    Chlorpheniramine polistirex; codeine polistirex
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TUZISTRA™ XR safely and effectively. See full...
    • ...12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES 16 HOW SUPPLIED/STORAGE...
  8. Letter

    Action date:
    FDA Application:
    NDA207768
    Drug:
    Tuzistra xr
    Active Ingredients:
    Chlorpheniramine polistirex; codeine polistirex
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207768 NDA APPROVAL Tris Pharma, Inc. 2033 Route 130...
    • ...NDA 207768 Page 2 CONTENT OF LABELING As soon as possible, but no later than 14 days from the date of this letter, submit the content of labeling [21...
  9. Summary Review

    Action date:
    FDA Application:
    NDA207768
    Drug:
    Tuzistra xr
    Active Ingredients:
    Chlorpheniramine polistirex; codeine polistirex
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 2077680rig1s000 SUMMARY REVIEW...
    • ...Division Director Review NDA 207-768 Tuzistra XR (codeine polistirex and chlorpheniramine polistirex) Extended Release Oral Suspension Summary Review...
  10. Label

    Action date:
    FDA Application:
    NDA207648
    Drug:
    Smoflipid 20%
    Active Ingredients:
    Fish oil; medium chain triglycerides; olive oil; soybean oil
    • ...-------------------------------CONTRAINDICATIONS-----------------------------• Known hypersensitivity to fish, egg, soybean, or peanut protein...
    • ...1 FULL PRESCRIBING INFORMATION WARNING: DEATH IN PRETERM INFANTS • Deaths in preterm infants after infusion of intravenous lipid emulsions have been...